Table 1

Summary of baseline characteristics* in randomised patients and previous TNF inhibitor use among patients receiving MTX at baseline

 MTX use at baselineNo MTX use at baseline
PlaceboGolimumabPlaceboGolimumab
Randomised patients*, n10720548101
Women89 (83.2%)160 (78.0%)43 (89.6%)75 (74.3%)
Age—years54.8±12.9453.5±12.2354.8±13.5054.4±11.07
Disease duration—years12.4±8.9411.2±8.3412.3±10.9612.0±9.19
Swollen joint count (0–66)17.0±11.9016.0±10.0218.6±11.4717.8±12.12
Tender joint count (0–68)29.8±18.0929.1±16.2030.3±16.5031.4±17.85
Rheumatoid factor positive69 (67.0%)137 (69.5%)41 (85.4%)76 (77.6%)
HAQ-DI (0–3)1.6±0.581.4±0.631.6±0.711.7±0.68
CRP (mg/L)20.8±31.7019.4±30.6220.2±31.5924.6±33.94
ESR (mm h)38.9±24.9434.6±28.1037.3±29.2640.4±28.97
DAS28-CRP score5.7±1.015.7±1.045.7±1.166.0±1.05
DAS28-ESR score6.3±1.106.1±1.246.2±1.376.5±1.24
Number of Prior TNF inhibitors
1 TNF inhibitor2 TNF inhibitors3 TNF inhibitors
Golimumab-randomised MTX-treated patients, n1374717
Prior TNF inhibitor
Adalimumab onlyEtanercept onlyInfliximab only
Golimumab-randomised patients who received only one prior TNF inhibitor, n334757
Reason for discontinuation of prior TNF inhibitor
 Lack of efficacy22 (66.7%)23 (48.9%)22 (38.6%)
 Intolerance5 (15.2%)2 (4.3%)8 (14.0%)
 ‘Other’ reason6 (18.2%)22 (46.8%)27 (47.4%)
Distribution by duration of prior treatment, n
 <4 weeks252
 ≥4 to <12 weeks8124
 ≥12 to <24 weeks734
 ≥24 to <36 weeks553
 ≥36 to <48 weeks128
 ≥48 weeks102036
 % patients receiving therapy for ≥24 weeks48.5%57.4%82.5%
  • Data presented are number (%) of patients or mean±SD unless otherwise noted.

  • *Baseline characteristics are summarised for all randomised patients with available data.

  • †Efficacy-related patient subgroups exclude patients from a single site due to violations at the study site identified during the Sponsor's standard audit processes.

  • ‡In the vast majority of patients, the ‘other’ reason for discontinuation of previous anti-TNF agent(s) was related to cost/insurance coverage.

  • CRP, C reactive protein; DAS28, 28-joint Disease Activity Score; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire Disability Index; MTX, methotrexate; TNF, tumour necrosis factor.